NL-OMON44573已完成3 期
Immune phenotyping in chronic HCV patients treated with Sofosbuvir and Daclatasvir combination for 12 or 24 weeks * SODA study - AI444-281
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed written informed consent
- •- Willingness to sign the written ICF.
- •2. Target population
- •- Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment to study, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C.
- •- Subjects infected with HCV genotype 1, 3 or 4 on screening laboratory test OR previous availaible documentation of HCV genotype 1,3 or 4 genotype.
- •- Treatment-naïve to or relapsed after any previous antiviral therapy other than combination of sofosbuvir + NS5A inhibitor ± ribavirin. Relapse is defined as the recurrence of HCV RNA following the termination of a full course of treatment and after having achieved an undetectable HCV RNA during treatment.
- •3. Age and reproductive status
- •- Age: 18 - 65 years
- •- Subjects must agree to use birth control (condoms) from the time of dosing until 90 days after the follow-up visit; male or female patients who are surgically sterile need not to employ a method of contraception
- •4. Laboratory test findings
- •- Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
- •o Platelets >50x10^9/L
- •o Total white blood cells >3.0x10^9/L and absolute neutrophil count >1.5x10^9/L
- •o Hemoglobin >6.8 mmol/L for females and >7.4 mmol/L for males
- •o Total and direct bilirubin < 2 x ULN
- •o ALT < 10 x ULN
- •o Serum creatinine within normal limits and estimated creatinine clearance rate as calculated by the Cockcroft-Gault formula >50 mL/min
- •- Negative results on the following screening laboratory tests: HBsAg and HIV antibody OR previous availaible documentation within 1 year before screening of HBsAg and HIV antibody negativity.
排除标准
- •- Other known cause of liver disease except for CHC
- •- History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, or other signs of hepatic insufficiency or portal hypertension
- •- History of hepatocellular carcinoma
- •- Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results
- •- History of relevant drug and/or food allergies
研究者
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